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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K221955
Device Name Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
Applicant
Realcloud Imaging Inc. Dba Realcloud Imaging
2625 N. Loop Dr., Suite 2130
Ames,  IA  50010
Applicant Contact Douglas A Golay
Correspondent
W. Edward Johansen
1239 Stanford St., Apt. Number 205
Santa Monica,  CA  90404
Correspondent Contact Ed Johansen
Regulation Number872.1800
Classification Product Code
MUH  
Date Received07/05/2022
Decision Date 08/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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